At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- BNT323 (drug), BNT327 (drug)
- How long the study runs
- Study runs about 52 months (dates as stated)
- About the drug or intervention
- BNT323 — drug: Intravenous infusion · BNT327 — drug: Intravenous infusion
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 380
- Started
- 2025-04-23
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for locally advanced breast cancer
- • Phase1/Phase2 - 380 participants
- • This is a Phase I/II, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination with BNT327 (also known as pumitamig and PM8002) in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor receptor (HER)2-positive, HER2-low (immunohistochemistry \[IHC\] 1+ or IHC 2+/in situ hybridization -), HER2-ultralow (IHC 0, with membrane staining) or HER2-null breast cancer (BC), or triple-negative breast cancer (TNBC)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with locally advanced breast cancer
Where?
- • Cambridge - Addenbrooke s Hospital
- • Cardiff - Velindre Cancer Centre
- • Leeds - St James's University Hospital
- • London - Royal Free Hospital
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a Phase I/II, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination with BNT327 (also known as pumitamig and PM8002) in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor receptor (HER)2-positive, HER2-low (immunohistochemistry \[IHC\] 1+ or IHC 2+/in situ hybridization -), HER2-ultralow (IHC 0, with membrane staining) or HER2-null breast cancer (BC), or triple-negative breast cancer (TNBC).
More detail
The study consists of two parts: * Part 1 - Dose escalation: In this part of the study, participants with histologically confirmed, chemotherapy-pretreated advanced HR+, HER2-low or HER2-ultralow BC will receive BNT323 in combination with BNT327 (BNT323 + BNT327) in a dose escalation design. This will define the recommended Phase 2 dose (RP2D) for the BNT323 + BNT327 combination therapy. * Part 2 - Dose optimization and exploratory cohorts: This part of the study will be an expansion phase, aiming to evaluate the efficacy and safety of the optimal dose combination and providing a more robust comparison against the other treatments. It will start once the enrollment in Part 1 is completed and the sponsor in conjunction with the Safety Review Committee has assessed available Part 1 efficacy and safety data. Part 2 of the study will have four cohorts, i.e., Cohorts 1 (dose optimization cohort), and Cohorts 2, 3, and 4 (exploratory cohorts). Recruitment to Cohorts 2, 3, and 4 will begin with RP2D from Part 1 and in parallel to randomization in Cohort 1. Randomization is planned for Cohort 1 in Part 2, i.e., participants will be randomized in 2:2:1:1 ratio into one of the four arms (Arms 1-4). No randomization is planned for any other cohort in Part 2.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Who cannot take part
- ✗Have history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose...
- ✗Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially...
- ✗Had prior treatment with topoisomerase I inhibitors, including antibody-drug conjugates with topoisomerase I...
- ✗Have received any of the following therapies or drugs prior to the initiation of the study:
- ✗Participants who have received prior treatment with BNT323.
See the full criteria
Where Is This Study? (7 UK sites)
Addenbrooke s Hospital
Cambridge CB2 0QQ, United Kingdom
Velindre Cancer Centre
Cardiff CF14 2TL, United Kingdom
St James's University Hospital
Leeds LS9 7TF, United Kingdom
Royal Free Hospital
London NW3 2QG, United Kingdom
Royal Marsden Hospital
London SW36JJ, United Kingdom
The Christie Hospital
Manchester M20 4BX, United Kingdom
Royal Marsden Hospital-Sutton
Sutton SM2 5PT, United Kingdom
How to Get in Touch
BioNTech clinical trials patient information
Sponsor contactCONTACT
